New Grant available to the Sickle Cell Community

New RFP-  Additional Centers for the Sickle Cell Disease Clinical Research Network funded under NIH grant number U10HL083721

 RELEASE DATE: September 2, 2008  Deadline to apply November 3, 2008

The Sickle Cell Disease Clinical Research Network (SCDCRN) is seeking to expand the number of research centers for participation in multi-center clinical studies over the remainder of its funding cycle (through March 31, 2011).  The SCDCRN was established through a cooperative agreement (U-10) National Heart, Lung and Blood Institute (NHLBI) Request for Applications (RFA HL-05-006) and currently consists of eight clinical research centers, two patient outcomes cores, and a Data Coordinating Center (DCC), New England Research Institutes, Inc (NERI).  Support for the SCDCRN included funds for the inclusion of additional sites as needed to complete clinical studies.  Up to 12 additional clinical research centers will be added. 

Initiation of at least two major studies is anticipated within the next 6 months which will require additional sites to achieve subject accrual goals: 

PROACTIVE is a randomized controlled trial to determine if a single simple transfusion can reduce the incidence of acute chest syndrome in patients with sickle cell disease (all genotypes >2 years of age) hospitalized for pain crises.  Hospitalized patients will be screened daily with a serum phospholipase A2 level to be established in the local laboratory to identify those at high risk of impending acute chest syndrome.  High risk patients will be randomized to a simple transfusion or standard care; presence or absence of a new infiltrate on a chest radiograph done at 72 hours after randomization and/or as clinically indicated will serve as study endpoint.  It is anticipated that at least 870 pain episodes will need to be screened to identify 120 subjects needed for randomization. 

The Losartan study will consist of two parallel placebo-controlled trials to determine if Losartan can retard the progression of renal disease in patients with sickle cell disease (all genotypes, age ≥ 12 years of age).  Patients with microalbuminuria (urine protein 30 – 299 mg/g creatinine) will be enrolled in one trial, while patients with macroalbuminuria (urine protein > 300 mg/g creatinine) will be enrolled in the other.  Each patient will be followed for up to four years with quarterly measurements of renal function and protein excretion.  It is anticipated that 4700 subjects > age 12 years of age will be need to be screened for either micro- or macroalbuminuria to identify the 450 subjects needed for enrollment and randomization.

For the full RFP as a PDF click here

New RFP for Sickle Cell Pain Research

Roadmap Transformative R01 Program (R01) (RFA-RM-08-029)
NIH Roadmap Initiatives Application Receipt Date(s): January 29, 2009
http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-08-029.html

Transitions from Acute to Chronic Pain

More than 30 million Americans suffer from unrelieved chronic pain. Management strategies often fail, in part because an individual's
susceptibility to chronic pain is highly variable, the identification of those destined to transition from acute to chronic pain is difficult,
and, once pain has become chronic, changes may have occurred that cannot be easily reversed. The lack of well defined phenotypes that reflect the
cellular, molecular, genetic, psychological, cognitive, and behavioral changes that occur as individuals transition to chronic pain has been a
major barrier to development of personalized approaches to pain intervention. For these reasons, T-R01 proposals are sought that will
transform how we view the pain state of individuals and that will revolutionize the current empirically-based analgesic treatment
approaches to ones based upon objective and predictive measures of an individual's pain phenotype. It is anticipated that responsive studies
will involve formation of innovative partnerships including interdisciplinary and multidisciplinary teams to adequately address the
topic and experimental aims.

Title: Meetings, Conferences, and Networks for Research Partnerships to Improve Functional Outcomes (R13)

Details at http://grants.nih.gov/grants/guide/pa-files/PAR-08-207.html

Background

In 2004, the NIH Rehabilitation Coordinating Committee developed a program announcement (PAR-04-077) entitled  “Research Partnerships to Improve Functional Outcomes” in order to stimulate multi-disciplinary research into the difficult problems of chronic disease and rehabilitation  The goal of this initiative was to encourage applicants with clinical expertise in rehabilitation or management of chronic disease to partner with scientists outside their fields to develop innovative approaches to problems.  Although the announcement did generate a number of responsive applications across a wide scope of research problems, most applicants had significant difficulties in articulating how the expertise of their teams would actually go about addressing their chosen problems.  In other words, applicants were successful in recruiting appropriate multi-disciplinary teams, but not in working with them to forge coherent research plans.

Goals

The present FOA attempts to address this problem by supporting meetings and workshops to bring together investigative teams to facilitate the process of developing appropriate research plans.  We seek to help investigators who have the same interests in solving particular problems of rehabilitation and chronic disease, including mental disorders, and who have complementary research or clinical expertise and/or resources team up and form partnerships to coordinate, exchange, and disseminate information or to explore or clarify a defined subject, problem or area of knowledge.  Proposed workshops and conferences should especially address issues in research methodology, including (but not limited to) selection of appropriate subjects, sample size, subject recruitment, measurement, trial design, and analytic strategies.  It is anticipated that these workshops and conferences will help investigators become successful in submitting competitive applications for investigator-initiated research projects in the future.

New Sickle Cell Newborn Grant 11/07

Posted Date: Nov 02, 2007
Creation Date: Nov 02, 2007
Original Closing Date for Applications: Dec 04, 2007 
Current Closing Date for Applications: Dec 04, 2007 
Archive Date: Feb 02, 2008
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Health
Category Explanation: 
Expected Number of Awards: 1
Estimated Total Program Funding: $800,000
Award Ceiling: $750,000
Award Floor: $750,000
CFDA Number: 93.110 -- Maternal and Child Health Federal Consolidated Programs
Cost Sharing or Matching Requirement: No 

Agency Name

Health Resources & Services Administration 

Description

The purpose of this grant activity is to fund a cooperative agreement to support the grantee program addressing Sickle Cell disease and newborn screening as well as follow-up of infants identified with Sickle Cell disease or as carriers. This initiative will provide models, best practices, and dissemination strategies for ensuring optimal follow-up and management of babies identified with Sickle Cell disease and/or as carriers. The purpose of this cooperative agreement is to fund a national Sickle Cell disease organization that will partner with families, community-based Sickle Cell disease organizations, health care professionals, State agencies including State Title V and newborn screening programs, and MCHB and its National Newborn Screening and Genetics Resource Center, the Regional Genetics and Newborn Screening Resource Center, and the Sickle Cell Disease Treatment Program National Coordinating Center. It will serve as a national Sickle Cell disease coordinating center to deal with issues related to educational materials, a common data base, evaluation, counselor certification, partnership building and information exchange. It will also support implementation of 17 community-based Sickle Cell disease projects funded to enhance the follow-up component of State Sickle Cell disease screening programs and support community-based efforts that provide hemoglobinopathy counseling, Sickle Cell disease-related education, and a community forum between MCHB and the Sickle Cell disease community to identify and prioritize issues important to the Sickle Cell disease community. Funds available: $800,000 for one cooperative agreement. The cooperative agreement will be funded for 3 years subject to the availability of funding for years 2-3 and satisfactory grantee performance.

Link to Full Announcement

https://grants.hrsa.gov/webExternal/SFO.asp?ID=88025630-9EB6-4767-B814-F7D96B9305A3 

10/1/06

NIH Grant RFP Mechanisms, Models, Measurement, & Management in Pain Research (R01)  http://grants.nih.gov/grants/guide/pa-files/PA-06-544.html and http://grants.nih.gov/grants/guide/pa-files/PA-06-542.html for R21

Pain is a critical national health problem.  It is the most common reason for medical appointments, and costs this country over $100 billion each year in health care and lost productivity.  Chronic pain affects more than 50 million Americans per year.  Pain often results in disability and, even when not disabling, it has a profound effect on the quality of life.  Its deleterious effects have been demonstrated in morbidity, immune function, sleep, cognition, eating, mobility, affective state, psychosocial behaviors, and overall functional status.  In the hospitalized patient, pain may be associated with increased length of stay, longer recovery time, and poorer patient outcomes, which in turn have health care quality and cost implications.

The NIH Pain Consortium was established in 1996 to enhance pain research and promote collaboration among researchers across the many NIH ICs that have programs and activities addressing pain.  Currently, the research interests of twenty-one NIH Institutes, Centers, and Offices are represented in the Consortium.  Although these combined efforts have resulted in great scientific progress, the understanding and treatment of pain remains incomplete.  Congress declared 2001 to 2010 the Decade of Pain Control and Research.  NIH continues to be responsive to and in alignment with this decade.  In presenting new pain findings, the April 2006 NIH Pain Consortium symposium “Advances in Pain Research” reiterated this need for an ongoing multidisciplinary research agenda that will ultimately lead to the prevention or effective treatment of unwanted pain. 

The NIH Pain Consortium requests research on all conditions in which pain is a prominent feature.  Of interest are conditions, such as cancer, that of themselves or their treatment may result in pain.  Many primary conditions, whether acute (such as injury), recurring (such as migraine), or chronic (such as arthritis) are significantly complicated by comorbid pain.  Some pain conditions are unassociated with other primary diagnoses.  Chronic pain is widely believed to represent a disease itself, causing long-term detrimental physiologic changes and requiring unique assessments and treatments.  Although not an exhaustive listing, and in addition to the areas of research detailed below in this FOA, of special interest are the following acute and chronic pain conditions:

6/06 The National Heart, Lung, and Blood Institute (NHLBI) invites applications for the renewal of the Comprehensive Sickle Cell Center program, whose purpose is to conduct comprehensive research, training, and education efforts related to sickle cell disease.  Comprehensive Sickle Cell Centers will conduct research to improve our understanding of sickle cell disease pathophysiology, and to develop cures or improved medical management modalities for this disease. Multi-center clinical research projects will be required. In addition, early stage clinical research or basic research (at least one of the two) will be required. Finally, translational research, health services research and high-risk, short-term basic research will be new required components in this funding cycle.   Up to $118.4 million (total costs) will be awarded over 5 years. http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-06-008.html

The Robert Wood Johnson Foundation has just posted a Call for Proposals related to:  Vulnerable Populations. Local Initiative Funding Partners Program 2006  Application Deadline: Jun 30, 2005 -  Local Initiative Funding Partners is a partnership program between RWJF and local grantmakers that supports innovative, community-based projects to improve the health and health care for society's most vulnerable people. For the application in PDF format http://www.rwjf.org/files/applications/cfp/cfp-lifp2006.pdf  More information at 
at: http://www.lifp.org

RWJF Sponsors Community-Based Health Grants
http://www.jointogether.org/y/0,2521,576628,00.html

The Local Initiative Funding Partners (LIFP) program, sponsored by the Robert Wood Johnson Foundation, is seeking applications for community-based health projects.

The LIFP will provide up to 18 matching grants ranging from $100,000 to $500,000 for its 2006 grant cycle. Applicants should present innovative community projects aimed at improving health and health care for populations in need. Existing programs are not eligible for this grant, with the exception of those undergoing extensive expansion.

New Grant RFP -   Research on Emergency Medical Services for Children at  http://grants1.nih.gov/grants/guide/pa-files/PA-05-081.html  - This multi-agency program announcement is designed to improve the quality and quantity of research related to emergency medical services for children (EMSC), with the goal of reducing morbidity and mortality in children through improved care delivery. This funding opportunity invites the submission of applications dealing with the following areas of research included under the term EMSC: prevention research to reduce the need for emergency care; clinical research to ensure that children receive high-quality and appropriate medical, nursing and mental health care in an emergency; health systems research, from pre-hospital care, to the emergency department, to in-patient care and return to the community; cost-effectiveness analyses; and methodological studies to improve the quality of research conducted. 

Junior Faculty Scholar Awards Sponsor: American Society of Hematology
The sponsor provides an award designed to encourage hematologists to begin a career in research by providing partial salary or other support during that critical period required for completion of training and achievement of status as an independent investigator.
Deadline(s): 05/04/2005
Contact: Karin Lombardi , Address: 1900 M Street, N.W.
Suite 200
Washington, DC 20036
E-mail: klombardi@hematology.org
Program URL: http://www.hematology.org/awards/scholar.cfm
Tel: 202-776-0544x1157
Fax: 202-776-0545
DEADLINE NOTE Letters of intent are due May 4, 2005. Applications are due
September 1, 2005.

2/15/05The NIH National Center on Minority Health and Health Disparities (NCMHD) has 
just released a request for applications for Community Participation in Health 
Disparities Intervention Research (http://www.ncmhd.nih.gov/)

Request For Applications (RFA) Number: RFA-MD-05-002
Letters of Intent Receipt Date(s): March 14, 2005
Application Receipt Dates(s): April 14, 2005
Peer Review Date(s): July-August 2005
Council Review Date(s): September 2005
Earliest Anticipated Start Date: September 2005
Expiration Date: April 15, 2005

The ultimate goal of this RFA is to support intervention research on health 
disparities that is jointly conducted by communities and researchers. This RFA 
will utilize the NIH resource-related research projects (R24) grant award 
mechanism. The total amount to be awarded is $4.5 million. The anticipated 
number of awards is 5-10.

Eligible organizations include not-for-profit and for-profit, public or private 
organizations, units of state and local governments, eligible agencies of the 
Federal Government, domestic institutions/organizations, faith-based or 
community-based organizations, and Native American tribal organizations.

Eligible principal investigators are any individuals with the skills, 
knowledge, and resources necessary to carry out the proposed research.
Each applicant may submit only one application in response to this RFA.

The PHS 398 application instructions are available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

The goal of this RFA is to support community-based participatory research in 
planning, implementing, evaluating and disseminating effective interventions 
for a disease or condition to reduce and eventually eliminate health 
disparities through partnerships between minority health populations, 
subpopulations, and other heath disparity populations and researchers.

Community-based participatory research (CBPR) is defined as scientific inquiry 
conducted in communities and in partnership with researchers. The process of 
scientific inquiry is such that community members, persons affected by the 
health condition, disability or issue under study, or other key stakeholders in 
the community's health have the opportunity to be full participants in each 
phase of the work (from conception - design - conduct - analysis - 
interpretation - conclusions - communication of results). CBPR is characterized 
by substantial community input in the development of the grant application 
(http://www.niehs.nih.gov/translat/cbpr/cbpr.htm).

For the purpose of this RFA, community refers to populations that may be 
defined by: geography, race, ethnicity, gender, illness, or other health 
condition, or to groups that have a common interest or cause, such as health or 
service agencies and organizations, health care or public health practitioners 
or providers, policy makers, or lay public groups with public health concerns. 
Community-based organizations refer to organizations that may be involved in 
the research process as members or representatives of the community. While not 
an exhaustive list, organizations as varied as Tribal governments and colleges, 
state or local governments, independent living centers, other educational 
institutions such as junior colleges, advocacy organizations, health delivery 
organizations (e.g., hospitals), health professional associations, 
non-governmental organizations, and federally qualified health centers are 
possible community partners.

In the NIH Health Disparities Strategic Plan, Fiscal Years 2004-2008, the 
health disparity populations are the racial and ethnic minority groups 
delineated within Section 1707(g), Public Law 106-25, as well as populations 
with low socioeconomic status and those living in rural areas. The racial and 
ethnic minority group refers to American Indians (including Alaska Natives, 
Eskimos, and Aleuts), Asian Americans, Native Hawaiians and other Pacific 
Islanders, Blacks and Hispanics. Hispanics are individuals whose origin is 
Mexican, Puerto Rican, Cuban, Central or South American, or any other 
Spanish-speaking country. The other health disparity populations are population 
groups who suffer health disparities when compared to the general population. 
(http://www.ncmhd.nih.gov)

NCMHD is interested in supporting intervention research studies using 
community-based participatory research (CBPR) principles to reduce and 
eventually eliminate health disparities in any disease or condition of major 
concern to the community (e.g. cancer, cardiovascular diseases, diabetes, 
HIV/AIDS, infant mortality, immunization) with emphasis on racial and ethnic 
minorities.

This initiative will start with a three-year planning grant, followed by a 
competitive five- year intervention grant, and conclude with a competitive 
three-year dissemination grant. Receipt of a planning grant does not guarantee 
obtaining the subsequent intervention or dissemination grant. Subsequent grant 
awards will be based on scientific merit, progress, quality of the research 
proposal, and availability of funds.

This RFA is inviting applications for a three-year planning grant proposal. The 
first year of the grant is devoted to partnership development, community needs 
assessment, identifying the disease/condition for intervention research, and 
planning the intervention methodology with substantial input from the 
community. During the second and third year, a pilot intervention research 
study will be conducted with community participation.

Successful partnership development with a defined community and developing a 
plan for intervention research including a pilot intervention research study 
using CBPR principles are required for participating in the competition for the 
next stage of funding for the intervention research grant.

For details, visit
http://grants.nih.gov/grants/guide/rfa-files/RFA-MD-05-002.html

12/1/04 NIH is encouraging individuals from underrepresented groups to participate as researchers in NIH-funded projects through a grant entitled Research Supplements to Promote Diversity in Health-Related Research. Only principal investigators that are currently conducting research with certain types of NIH research grants may apply for this grant. 

This administrative supplemental grant is to support and recruit students, post doctorates, and eligible investigators from groups that have been shown to be underrepresented, such as certain racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically or educationally disadvantaged backgrounds. 

Over $60 million is expected to support over 1,000 grants. Individual awards will range greatly from under $5,000 to over $75,000 depending on the career level of the candidate. Applications can be sent at anytime. The program announcement is at:
http://grants.nih.gov/grants/guide/pa-files/PA-05-015.html

See all NHLBI Requests for Applications (RFAs) http://www.nhlbi.nih.gov/funding/inits/

The NIH Office of Extramural Research (OER), has announced the posting of a
new website "that articulates NIH's continuing commitment to new investigators." The site is available at  http://grants.nih.gov/grants/new_investigators/index.htm  

HRSA  RFA -  HRSA will fund one cooperative agreement under the Sickle Cell Disease and Newborn Screening Program: National Coordinating and Evaluation Center. The successful applicant will provide assistance to currently funded sickle cell disease and newborn screening community-based projects. The Center will increase knowledge about sickle cell disease for the families affected, strengthen partnerships between HRSA-funded sickle cell disease community-based programs and partners, and improve the quality of sickle cell disease, newborn screening and carrier follow-up activities of the HRSA funded community-based programs.

Interested applicants are referred to the program announcement for the specific goals expected of the grantee for each year of the funded three-year project. A total of up to $750,000 will support one cooperative agreement. Applications are due January 24, 2005. The application guidance document can be found at: http://www.hrsa.gov/grants/preview/guidancemch/hrsa05036.htm#1

9/10/04 - New RFP: INFORMAL CAREGIVING RESEARCH FOR CHRONIC CONDITIONS (including Sickle Cell Disease) - The National Institute of Nursing Research (NINR), the National Institute of  Child Health and Human Development (NICHD), and the National Institute of  Mental Health (NIMH) invite applications for research grants to advance the  science in informal caregiving by focusing on the caregivers of individuals  with chronic illness, disability, or functional impairment requiring partial  or full dependency on others. http://grants.nih.gov/grants/guide/pa-files/PA-02-155.html

1/26/04 Grant alert - Pulmonary Complications of Sickle Cell Disease 
SOURCE: National Heart, Lung, and Blood Institute (NHLBI)
APPLICATION DEADLINE: Letter of Intent: 4/26/04; Application: 5/24/04 
FUNDS AVAILABLE: $6 million in total costs in FY 2005 to fund 3 to 4 new and/or competitive continuation grants in response to this RFA. An applicant may request a budget for total costs of up to $2 million per year and a project period of up to 4 years.
ELIGIBILITY: Domestic or foreign, public or private nonprofit entities are eligible to apply, including units of State or local government, and community-based organizations, including faith-based organizations.
PURPOSE:The purpose of this initiative is to stimulate translational research on the pulmonary complications of sickle cell disease. The RFA encourages collaborative research between investigators in hematology and pulmonary science that combines basic and clinical approaches. This RFA will support 3-5 programs where pulmonary and sickle cell disease researchers conduct both basic science and clinical investigation to elucidate mechanisms for these complications and develop new treatments.
CFDA: 93.938, 93.939
CONTACT: Henry Chang, M.D., Division of Blood Diseases and Resources, NHLBI, (301) 435-0067, Fax: (301) 480-0868, E-mail: changh@nih.gov. For the full announcement see: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-04-015.html

10/20 03 MULTIDISCIPLINARY CLINICAL RESEARCH CAREER DEVELOPMENT PROGRAMS RELEASE DATE: October 20, 2003
RFA Number: RFA-HD-04-006 http://grants2.nih.gov/grants/guide/rfa-files/RFA-HD-04-006.html

New Grant Announcement 9/16/03 - EXPLORATORY AND DEVELOPMENTAL RESEARCH GRANTS FOR INVESTIGATIONS IN RARE  DISEASES (R21) RELEASE DATE: September 16, 2003
PA NUMBER: PA-03-171
EXPIRATION DATE: Sept 02, 2006, unless reissued
Department of Health and Human Services (DHHS)
http://grants1.nih.gov/grants/guide/pa-files/PA-03-171.html

New Grant announcement 8/6/03 - CHRONIC ILLNESS SELF-MANAGEMENT IN CHILDREN  - RELEASE DATE: August 6, 2003  PA NUMBER: PA-03-159 http://grants1.nih.gov/grants/guide/pa-files/PA-03-159.html

The NIH Office of Extramural Research: Current News Flashes & Archives 
 page at http://www.nhlbi.nih.gov/funding/inits/index.htm

The Comprehensive Sickle Cell Centers (CSCC) Collaborative Clinical Trial Consortium (CCTC) was recently constituted under the aegis of the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), by a peer-reviewed, competitive process, and comprises ten Sickle Cell Centers in the USA. Patient populations at all sites include approximately 7500 individuals (pediatric and adult) with sickle cell syndromes. One of the major goals of the new CSCCs is the conduct of interventional collaborative clinical trials of high merit that will make a difference in the life of the individual with sickle cell disease. To this end, clinical investigators from both CSCCs and non-CSCC Centers are being solicited for meritorious collaborative clinical proposals that will be considered for potential funding in the current five-year funding cycle that commenced in April, 2003.

As a clinical investigator in the area of sickle cell disease, we are notifying you of the CSCC goals for performing such meritorious clinical research, and the procedure that has been set up for your potential participation via a "concept proposal" application. Enclosed is the format necessary for all submissions, including the address to which such proposals should be sent, and the deadlines involved. Please note that your submission should not exceed the stipulated length of 3 pages inclusive of all 14 items outlined. The Steering Committee of the CSCC CCTC is comprised of the Principal Investigator and one co-investigator from each of the 10 funded CSCCs and the Statistics and Data Management Center (coordinating center), and one representative from NHLBI, for a total of 23 members. The Steering Committee will rate such clinical concept proposals on the merits and feasibility of testable hypotheses, the need for a multi-center network to meet the proposal’s stated goals, and study recruitment feasibility, among other considerations. Proposals can be Phase I-III but should also be able to be successfully completed by April, 2008. Please be aware that the annual budget for studies run by the CSCC CCTC will be approximately $3.6 million, and this amount must support all concurrent trials (we expect 2-4 studies to be running concurrently at any given time).

Proposals will be solicited, coordinated, and preliminarily reviewed by the Outside Projects Subcommittee to the Steering Committee. Non-CSCC (external) proposals will be considered fairly alongside CSCC (internal) proposals, and Investigators of concept proposals deemed to be of the highest priority will be invited to make a formal presentation to the Steering Committee, either in person or on one of our monthly conference calls. The Steering Committee has already initiated the first round of such concept proposals, with the selection of two outstanding clinical trials now under development for initiation later this year. For this initial round, in the interests of demonstrating research productivity as rapidly as possible, we focused on internal proposals only. It is our goal to identify the next cohort of highly meritorious proposals in a timely manner, such that their translation from the drawing board to reality can be accomplished within the next 12 to 18 months.

While we are very interested in seeing your best ideas for translational research in sickle cell disease, we also have to be frank about the likelihood of any given proposal being implemented by the CSCC CCTC. We anticipate that only 5-7 collaborative clinical trials can be implemented between now and April, 2008, of which two have already been identified. You can expect therefore that your proposal will be competing against approximately 10 to 12 others of internal or external origin.

If your proposal is chosen for implementation by the Steering Committee, your direct participation in the design and conduct of the study is welcome and will be expected. However, please take note that these are cooperative and collaborative studies, and the Steering Committee as a group (not any one individual), will have responsibility for design and conduct of the study. In addition, by establishing a financial relationship with one of the 10 CSCCs, it will be possible for your Center to receive NIH funds to participate in your study (via subcontract from the Core CSCC you have made an arrangement with). These funds will be in the form of a per-patient reimbursement for study costs, plus time spent on the study by the site PI and nurse coordinator.

Proposals from industry (for-profit organizations) are welcome. We expect that for-profit organizations will give due consideration to sole sponsorship, or co-sponsorship of CSCC CCTC studies that they propose, but contribution of funds is not absolutely required for projects with great merit.

Proposals from foreign organizations (outside the US) are welcome. Participation of the CSCC CCTC in international studies, where no NIH funds are sent outside the US, is possible pending approval of the Director, NHLBI. Consideration will be given to transfer of NIH funds to foreign sites only in cases where there are unique patient resources to be contributed, and the project in question is otherwise extraordinarily meritorious. This is true regardless of whether the foreign center has established a collaboration with a US site or not.

We hope that this solicitation will bring outstanding collaborative clinical trials in the area of Sickle Cell Disease to the attention of the CSCC Steering Committee. It is only through such collaborative efforts, conducted under the most rigorous standards, that we can provide answers that will enhance the quality of life of the individual with this disease.

Sincerely,

Marie J. Stuart, M.D.Chair, Outside Projects Committee, Comprehensive Sickle Cell Centers

Completed Applications should be posted and sent via E-mail to: Mr. Jeff Oberhaus RHO, Inc. 100 Eastowne Drive Chapel Hill, NC 27514 E-mail: joberhau@rhoworld.com Fax: (919) 929-6330 Phone: (919) 929-6200 x329 Applications will be received quarterly over the next 18 months with strictly enforced deadlines as follows: June 15^th 2003, August 15^th 2003, November 1^st 2003, March 1^st 2004, June 1^st 2004, September 1^st 2004, November 1^st, 2004

Please follow the format outlined below when providing a summary of your proposed collaborative trial – Your proposal should not exceed 3 pages:

1. Principal Investigator and Institution:

2. Title of Protocol:

3. Objective:

4. Specific Aim(s):

5. Study Population: (Include type of disease(s), age range, eligibility and exclusion criteria.)

6. Treatment Plan: (Include type of experimental treatment agent, if applicable.)

7. Measurements to be Performed:

9. Secondary Outcome(s):

10. Study Design: Cohort ___  Case-control ___ Clinical Trial ___ Phase I II III Masked Yes No  Randomized Yes No  Crossover Yes No

Estimated Sample Size ________________

Accrual Period (duration) ________________

Follow up Period (duration) ________________

11. IND/IDE Required? Yes No

12. Summary of Annual Estimated Costs Per Patient and Total Study Time:

13. Statistical Power Calculations:

14. Study Timeline:

If you know of a grant that would benefit sickle cell patients and researchers, please send it to aplatt@emory.edu

Send mail to aplatt@emory.edu with questions or comments about this web site.
Copyright © 1997 Sickle Cell Information Center
Last modified: May 18, 2009